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卫生部北京生物制品研究所从美国默克公司引进的重组酵母乙型肝炎疫苗生产技术,1992年开始按工业化生产要求进行生产线的安装、试运行,通过不断地消化先进技术,使其适合我国的条件,到目前为止,经过3年的努力,所生产的疫苗经中国药品生物制品检定所检定、国家新药评审委员会审评,认为达到了国家规定的标准,卫生部批准用于预防乙型肝炎。 重组酵母乙型肝炎疫苗可引发细胞与体液的免疫应答,有很高的预防效果。疫苗中所含的HBsAg,生物学性状稳定。该疫苗仅含有来源于DNA重组技术构建的酵母菌表达的HBsAg,不可能污染其它病毒,所以比血源乙肝疫苗更为安全。由于免疫原性好,可降低免疫剂量,每程免疫仅需5μg。母婴传播阻断效果更为显著,重组疫苗5μg,阻
Ministry of Health Beijing Institute of Biological Products Merck company introduced from the United States recombinant yeast hepatitis B vaccine production technology, began in 1992 according to the requirements of industrial production production line installation, commissioning, through continuous digestion of advanced technology to make it suitable for our country Conditions, so far, after 3 years of hard work, the vaccine produced by the China Pharmaceutical and Biological Products Inspection, the review of the National Drug Evaluation Committee that the state has reached the standards set by the Ministry of Health approved for the prevention of hepatitis B. Recombinant yeast hepatitis B vaccine can cause cellular and humoral immune response, with a high preventive effect. The HBsAg contained in the vaccine is stable in biological properties. The vaccine contains only the HBsAg expressed by the yeast constructed by DNA recombination technology and can not pollute other viruses, so it is safer than the blood-borne hepatitis B vaccine. Due to good immunogenicity, can reduce the dose of immunization, each immunization only 5μg. Maternal and child transmission block effect is more pronounced, recombinant vaccine 5μg, resistance